BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 12123187 · Received July 6, 2021

    Report

    Report Number
    2916596-2021-03615
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 17, 2021
    Report Date
    September 12, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF LOW VOLTAGE ADVISORY AND NO EXTERNAL POWER ALARMS WAS CONFIRMED VIA THE SUBMITTED LOG FILE. THE LOG FILE CONTAINED APPROXIMATELY 1 DAY OF DATA (B)(6) 2021 ¿ (B)(6) 2021 PER THE TIMESTAMP). THE LOG FILE CAPTURED MULTIPLE LOW VOLTAGE ADVISORY, LOW VOLTAGE HAZARD, AND NO EXTERNAL POWER ALARMS DUE TO THE VOLTAGES LEVELS ON THE BLACK SYSTEM CONTROLLER POWER CABLE DROPPING WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU) ON (B)(6) 2021 FROM 20:29:15 TO 20:29:36 AND FROM 20:30:03 TO 20:30:21. THE WHITE SYSTEM CONTROLLER POWER CABLE WAS EITHER DISCONNECTED OR CONNECTED TO A 14V BATTERY DURING THE ALARMS. THE ALARMS RESOLVED EACH TIME WHEN THE WHITE SYSTEM CONTROLLER POWER CABLE WAS CONNECTED TO THE MPU. THE ALARMS DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. MULTIPLE REQUESTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION (INCLUDING IF THE MPU WILL BE RETURNING FOR EVALUATION); HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. HEARTMATE 3 PATIENT HANDBOOK UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE NO EXTERNAL POWER, LOW VOLTAGE ADVISORY/HAZARD, AND POWER CABLE DISCONNECT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. FURTHERMORE, THE SUBSECTION ¿WHAT NOT TO DO: DRIVELINE AND CABLES¿ INFORMS THE USER TO CHECK THE MPU POWER CABLES FOR TWISTING, KINKING, OR BENDING WHICH COULD CAUSE DAMAGE TO THE WIRES INSIDE. THIS SECTION INFORMS THE USER NOT TO ¿TWIST, KINK, OR SHARPLY BEND THE MPU POWER CABLES¿ AND STATES ¿IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN¿. HEARTMATE 3 PATIENT HANDBOOK SECTION 6 "CARING FOR THE EQUIPMENT" AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 8 ¿EQUIPMENT STORAGE AND CARE¿ DESCRIBE HOW TO CARE FOR AND CLEAN ALL EQUIPMENT, INCLUDING THE SYSTEM CONTROLLER. HEARTMATE 3 PATIENT HANDBOOK SECTION 10 AND HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION F, BOTH ENTITLED ¿SAFETY CHECKLISTS¿, PROVIDE CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE MPU. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) UNDER SECTION 3 ¿POWERING THE SYSTEM¿ EXPLAINS THE VARIOUS WAYS TO POWER THE HEARTMATE 3 LVAS, INCLUDING HOW TO PROPERLY USE THE MPU AND THE ACTIONS TO TAKE IN THE EVENT OF A POWER FAILURE. HEARTMATE 3 PATIENT HANDBOOK CAUTIONS USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S EVENT LOG DISPLAYED LOW_POWER_ADVISORY / NO_EXTERNAL_POWER ALARMS ON (B)(6) 2021 AT 8:30PM DUE TO POSSIBLE PATIENT ERROR WHILE TETHERED ON MOBILE POWER UNIT (MPU). THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THIS MAY BE DUE TO THE POWER CORD COMING LOOSE FROM THE WALL OUTLET OR THE HOUSE LOSING POWER. THE EVENT LOG DISPLAYED A COUPLE TRANSIENT BACKUP_BATTERY_FAULT ALARMS ON (B)(6) 2021 AT 8:30PM WHICH APPEAR TO HAVE RESOLVED. THERE WAS NO INTERRUPTION IN PUMP SUPPORT DURING THESE EVENTS. THERE WERE NO OTHER UNUSUAL EVENTS SEEN WITHIN THE LOG FILES. THE MCS EQUIPMENT IS OPERATING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020845 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR